Dry Eye and Contact Lens WearNCT01712022
Evaluation of Corneal Epithelial Thickness Mapping
An observational study of Dry Eye and Contact Lens Wear, run by Optovue at 3 sites in United States.
Trial summary
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Dry Eye and Contact Lens Wear
- How many people
- 88 participants
- Where
- 3 sitesUnited States
- Study dates
- Oct 2012to Nov 2013
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: seeing eye doctor for routine or follow-up care
Who may be able to join
- 18 years of age or older
- Able and willing to provide consent
- Able and willing to complete the required examinations
- DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
- CONTACT LENS GROUP ONLY: Regular contact lens wear
Who cannot join
- History of ocular surgery
- History of laser refractive surgery
- History of cataract surgery
- DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
- CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
- NORMAL GROUP ONLY: History of contact lens wear or dry eye or corneal pathology
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Brass Eye Center
Latham, New York, 12110
Fishman Vision
Palo Alto, California, 94301
Gordon-Weiss-Schanzlin Vision Institute
San Diego, California, 92122
About this study
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.
- Conditions
- Dry Eye and Contact Lens Wear
- Medical subject headings
- Dry Eye Syndromes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dry Eye | clinical diagnosis of dry eye | |
| Contact Lens | routine wear of contact lens | |
| Normal | Not having history of dry eye or contact lens wear or corneal pathology or surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
corneal epithelial thickness
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2012 (estimated)
- Study startOct 2012
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dry Eye and Contact Lens WearStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- Optovue
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01712022
- Sponsor's protocol ID
- 200-48071
- Status last verified
- Sep 2014
- First submitted
- 19 Oct 2012
- Last updated
- 11 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Corneal Epithelial Thickness Mapping
- ClinicalTrials.gov ID
- NCT01712022
- Acronym / sponsor ID
- 200-48071
- Conditions
- Dry Eye and Contact Lens Wear
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- OptovueIndustry (pharma, biotech, devices)
- Study start
- Oct 2012
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 23 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Optovue has developed a new feature for mapping corneal epithelial thickness. The purpose of the study is to evaluate the accuracy and repeatability of the epithelial thickness measurement. Consented subjects will undergo a series of cornea measurements using optical coherence tomography (OCT) that will be used for analysis.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dry Eye | – | –clinical diagnosis of dry eye |
| Contact Lens | – | –routine wear of contact lens |
| Normal | – | –Not having history of dry eye or contact lens wear or corneal pathology or surgery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- seeing eye doctor for routine or follow-up care
Key inclusion criteria (5 listed)
- 18 years of age or older
- Able and willing to provide consent
- Able and willing to complete the required examinations
- DRY EYE GROUP ONLY: Clinical diagnosis of dry eye
- CONTACT LENS GROUP ONLY: Regular contact lens wear
Key exclusion criteria (6 listed)
- History of ocular surgery
- History of laser refractive surgery
- History of cataract surgery
- DRY EYE GROUP ONLY: Corneal pathology not associated with dry eye
- CONTACT LENS GROUP ONLY: Corneal pathology including dry eye
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
corneal epithelial thickness
Time frame: Day 1
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dry Eye and Contact Lens Wear, run by Optovue at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
corneal epithelial thickness (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Sep 2014.